Details:

Corporate Authors:
Centers for Disease Control and Prevention (U.S.). Office of the Associate Director for Science.Office of Scientific Integrity.
Description:
This report describes an incident involving the potential exposure of a laboratory technician at the Centers for Disease Control and Prevention (CDC) to live (non-inactivated) Ebola virus. The incident occurred on December 22, 2014, on CDC’s Roybal Campus in Atlanta during procedures for a study being conducted as part of the public health response to the ongoing West Africa Ebola outbreak. The potential exposure of the laboratory technician resulted from the inadvertent transfer of potentially live Ebola virus from one of CDC’s high containment biosafety level 4 (BSL-4) laboratories to a lower biosafety level 2 (BSL-2) laboratory, where the laboratory technician processed the material. The laboratory technician completed 21 days of monitoring and reported no illness. Subsequent studies conducted at CDC have determined that the mistakenly transferred samples likely did not contain live virus, and posed no safety risk to CDC staff or the broader community.

The incident involved staff from CDC’s Viral Special Pathogens Branch (VSPB), which conducts public health research on highly pathogenic viruses and has played a central role in the Agency’s response to the current Ebola outbreak. Staff involved in the incident were conducting an animal-model study to gain information to help determine if the current strain of Ebola virus was more virulent compared to other outbreak strains and if oral fluid swabs could be used in disease diagnosis efforts. The study involved taking two oral swabs daily from each of the study animals and then placing the swabs in two sets of tubes—one designated for live-virus studies and the other for studies with inactivated material. The tubes were distinguishable only by colored caps and pre-printed labels. The incident occurred when the tubes designated for live-virus studies were mistakenly prepared for transfer out of the BSL-4 laboratory and then subsequently taken to the BSL-2 laboratory for additional studies. On December 23, CDC laboratory scientists involved in the study discovered the problem, took immediate steps to minimize the possible risk to workers in the BSL-2 laboratory, and promptly reported the incident to their leadership, with standard notifications made for select agent or toxin exposures. Leadership of the CDC BSL-4 laboratory where this incident occurred immediately suspended transfers out of the laboratory until a full review of the incident is completed and appropriate improvements are implemented. In addition to the internal investigation of the incident described in this report, per standard protocol, CDC’s Division of Select Agent and Toxins and the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture has conducted an investigation.

An internal investigation was conducted by a team of CDC laboratory scientists from other parts of the Agency, who interviewed persons directly involved with the incident as well as others who had specific knowledge of the incident and related activities. The overriding causes of this incident were related to inadequate safeguards, including lack of a written study plan that had been approved by a supervisor and a workflow that was not designed to sufficiently minimize the possibility that human error could result in exposure. Other underlying factors included lack of a centralized point of contact in VSPB for laboratory safety and select-agent compliance; lack of project oversight and continuity in day-to-day leadership; and the lack of full implementation of recent laboratory safety enhancement requirements, which may have had the potential to reduce the likelihood of this incident.

This report describes specific actions underway at CDC to improve laboratory safety, recommended actions for VSBP to address factors that may have caused or contributed to the incident, and actions to address issues identified from this incident that may have implications for all CDC BSL-3 and BSL-4 laboratories. Examples include ensuring full understanding and implementation of actions recommended as part of CDC’s ongoing laboratory safety improvement efforts, such as proper completion of a required form for materials taken out of CDC’s high containment laboratories to lower biosafety level laboratories and appropriate secondary verification measures for critical safety control points. New remediation actions specific for the VSPB laboratory include the designation of a senior scientist to ensure select-agent compliance. Broader recommendations for CDC’s BSL-3 and BSL-4 laboratories include the establishment of a peer review system of written research plans to help optimize workflows and minimize safety errors; the use of multiple, visual safeguards (e.g., coloring for liquids, distinctive size and shape for specimen handling and storage containers); and steps to improve safety for laboratory staff working outside of normal work hours.


Subjects:
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Containment Of Biohazards Ebolavirus Hemorrhagic Fever, Ebola Laboratory Infection/prevention & Control Occupational Exposure Safety Management Specimen Handling
Document Type:
Report
Place as Subject:
United States
Collection(s):
Stephen B. Thacker CDC Library collection
Main Document Checksum:
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urn:sha256:381eada18a9727bb6e38a536e716ea2f4ea0f2596b2b873d19b81c049abe84c6
Download URL:
https://stacks.cdc.gov/view/cdc/27408/cdc_27408_DS1.pdf
File Type:

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